Model Number 56-3618 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
|
Event Date 07/26/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Medical record received and was reviewed on mar 6, 2023.After review of medical record, patient was revised to address adverse local tissue reaction due to metallosis and wear of mom components.Patient experienced pain and elevated metal ion.Revision notes stated that there was extensive scarring due to the previous surgery.There was intraarticular fluid consistent with metallosis and metal wear debris and debriding all pseudotumor from around the hip and noted that the psoas sheath was swollen.The polyethylene liner which was non depuy was impacted ; however , the locking mechanism would not engage and was just slipping out easily and appeared to be broken.Screws were removed and acetabular component with minimal bone loss.Small amount of osteolysis posterior to the acetabulum was debrided.Doi: (b)(6) 2008 - dor: (b)(6) 2022 (right hip).
|
|
Manufacturer Narrative
|
Product complaint (b)(4).Investigation summary; no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot; the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Event Description
|
Medical record received.Medical records report synovium and soft tissue with degenerative and chronic inflammatory changes.Pigmented histiocytes are noted consistent with metallosis ("deposition" of metallic particulates).Fragments of bone and cartilage with degenerative and reactive changes.Metallosis noted.Bone marrow with trilineage maturing hematopoiesis.Also received are two metallic, threaded screws measuring 2.7 and 3.7 cm in length.
|
|
Search Alerts/Recalls
|